DK2407486T3 - Antagonistantistoffer mod GDF-8 og anvendelser i behandling af ALS og andre GDF-8-associerede lidelser - Google Patents

Antagonistantistoffer mod GDF-8 og anvendelser i behandling af ALS og andre GDF-8-associerede lidelser Download PDF

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DK2407486T3
DK2407486T3 DK11161564.7T DK11161564T DK2407486T3 DK 2407486 T3 DK2407486 T3 DK 2407486T3 DK 11161564 T DK11161564 T DK 11161564T DK 2407486 T3 DK2407486 T3 DK 2407486T3
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gdf
antibody
seq
amino acid
acid sequence
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Pamela Kelley
Xiang Yang Tan
Seung Poon Kwak
Karen Wallace
Nicholas Weber
Frank S Walsh
Margaret M Zaleska
David S Howland
Howland Erika L F Holzbaur
Lioudmila Tchistiakova
Riyez Karim
Menelas N Pangalos
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Wyeth Llc
Univ Pennsylvania
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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G01N33/6896—Neurological disorders, e.g. Alzheimer's disease
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    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
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    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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    • G01N2333/475—Assays involving growth factors
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Claims (28)

1. Humaniseret antistof, der specifikt binder og antagoniserer GDF-8, omfattende: en antistof variabel tung (VH) region, der har aminosyresekvensen af SEQ ID NO:7 eller der ikke adskiller sig med mere end 2 aminosyregrupper fra aminosyresekvensen af SEQ ID NO:7, og en antistof variabel let (VL) region, der har aminosyresekvensen af SEQ ID NO: 9 eller der ikke adskiller sig med mere end 2 aminosyregrupper fra aminosyresekvensen af SEQ ID NO:9; hvor den første CDR fra en VH-region (Hl) har aminosyresekvensen af SEQ ID NO: 10, den anden CDR fra en VH-region (H2) har aminosyresekvensen af SEQ ID NO: 11, den tredje CDR fra en VH-region (H3) har aminosyresekvensen af SEQ ID NO: 12, den første CDR fra en VL-region (LI) har aminosyresekvensen af SEQ ID NO: 13, den anden CDR fra en VL-region (L2) har aminosyresekvensen af SEQ ID NO: 14, den tredje CDR fra en VL-region (L3) har aminosyresekvensen af SEQ ID NO: 15, eller hvor den første CDR fra en VH-region (Hl) har aminosyresekvensen af SEQ ID NO: 20, den anden CDR fra en VH-region (H2) har aminosyresekvensen af SEQ ID NO: 21, den tredje CDR fra en VH-region (H3) har aminosyresekvensen af SEQ ID NO: 22, den første CDR fra en VL-region (LI) har aminosyresekvensen af SEQ ID NO: 23, den anden CDR fra en VL-region (L2) har aminosyresekvensen af SEQ ID NO: 24, den tredje CDR fra en VL-region (L3) har aminosyresekvensen af SEQ ID NO: 25.
2. Det humaniserede antistof ifølge krav 1, hvilket omfatter: en antistof variabel tung (VH) region, der har aminosyresekvens af SEQ ID NO: 7 eller der ikke adskiller sig med mere end 1 aminosyregruppe fra aminosyresekvensen af SEQ ID NO:7; og en antistofvariabel let (VL) region, der har aminosyresekvens af SEQ ID NO:9 eller der ikke adskiller sig med mere end 1 aminosyregruppe fra aminosyresekvensen af SEQ ID NO:9.
3. Det humaniserede antistof ifølge krav 1 eller krav 2, hvor VH-regionen omfatter aminosyresekvensen af SEQ ID NO:7, og VL-regionen omfatter aminosyresekvensen af SEQ ID NO:9.
4. Det humaniserede antistof ifølge et hvilket som helst af kravene 1 til 3, yderligere omfattende en tungkæde konstant region fra en immunoglobulin-subtype valgt fra gruppen bestående af IgGl, IgG2, IgG3, IgG4, IgAl, IgA2, IgD, IgE og IgM.
5. Det humaniserede antistof ifølge et hvilket som helst af kravene 1 til 4, yderligere omfattende en tungkæde konstant region fra human IgGl.
6. Det humaniserede antistof ifølge krav 4 eller krav 5, hvor den konstante region er ændret for at ændre egenskaberne af antistoffet.
7. Det humaniserede antistof ifølge krav 6, hvor den ændrede konstante region er muteret.
8. Det humaniserede antistof ifølge krav 6 eller krav 7, hvor den konstante region er ændret til at øge eller reducere Fc-receptorbinding.
9. Antistoffet ifølge krav 5, hvor den konstante region omfatter aminosyresekvensen af SEQ ID NO: 19.
10. Antistoffet ifølge krav 7, hvor den humane IgGl konstante region omfatter aminosyresekvensen af SEQ ID NO: 19 muteret ved en eller flere af resterne 117 og 120 deraf.
11. Antistoffet ifølge et hvilket som helst af kravene 1 til 10, yderligere omfattende en antistof letkæde konstant region valgt fra gruppen bestående af kappa og lambda.
12. Polynukleotid, der koder for antistoffet ifølge et hvilket som helst af kravene 1 til 11.
13. Polynukleotidet ifølge krav 12, der er funktionelt forbundet til en ekspressions-styringssekvens.
14. Vektor omfattende polynukleotidet ifølge krav 12 eller krav 13 som en GDF-8-antagonist.
15. Værtscelle omfattende vektoren ifølge krav 14 eller omfattende polynukleotidet ifølge krav 12 eller krav 13 som en GDF-8-antagonist.
16. Fremgangsmåde til fremstilling af et antistof, der specifikt binder GDF-8, omfattende trinnet at dyrke værtscellen ifølge krav 15 og at genvinde det derved fremstillede antistof.
17. Antistoffet ifølge et hvilket som helst af kravene 1 til 11 fremstillet ved hjælp af fremgangsmåden ifølge krav 16.
18. Sammensætning omfattende antistoffet ifølge et hvilket som helst af kravene 1 til 11 og 17, og en farmaceutisk acceptabel bærer. I
19. Sammensætningen ifølge krav 18 til anvendelse i behandling afen lidelse af et pattedyrsindivid, hvor lidelsen er valgt fra gruppen bestående af: en muskellidelse, en neuromuskulær lidelse, en knogledegenerativ lidelse, en adipøs lidelse, en metabolisk knoglelidelse, en induceret knoglelidelse, en i glukosemetabolisme lidelse og en insulin-relateret lidelse.
20. Sammensætningen til anvendelse ifølge krav 19, hvor lidelsen er yderligere valgt fra gruppen af lidelser bestående af: muskulær dystrofi, Duchenne muskulær dystrofi, muskelatrofi, organatrofi, svaghed, carpaltunnelsyndrom, I kronisk obstruktiv lungesygdom, amyotrofisk lateral sklerose (ALS), sarcopeni, kakesi, muskelsvindssyndrom, osteoporose, osteoporose-relateret fraktur, osteopeni, osteoarthritis, lav knoglemasse, reduceret glukosetolerans, insulinresistens, type-2 diabetes, fedme og metabolisk syndrom.
21. Sammensætningen til anvendelse ifølge krav 20, hvor lidelsen er Duchenne muskulær dystrofi.
22. Sammensætningen til anvendelse ifølge krav 20, hvor lidelsen er ALS.
23. Sammensætningen til anvendelse ifølge krav 20, hvor lidelsen er kakesi eller sarcopeni.
24. Sammensætningen ifølge krav 18 til anvendelse i behandling afen muskelsvindslidelse hos et pattedyrsindivid.
25. Sammensætningen til anvendelse ifølge krav 24, hvor muskelsvindslidelsen er et muskelsvindsyndrom eller HIV-induceret muskelsvind.
26. Sammensætningen til anvendelse ifølge et hvilket som helst af kravene 19 til 25, hvor pattedyrsindividet er et menneske.
27. Anvendelse af antistoffet ifølge et hvilket som helst af kravene 1 til 11, in vitro, i en diagnostisk fremgangsmåde.
28. Antistoffet ifølge et hvilket som helst af kravene 1 til 11 til anvendelse in vivo i en diagnostisk fremgangsmåde.
DK11161564.7T 2005-08-19 2006-08-14 Antagonistantistoffer mod GDF-8 og anvendelser i behandling af ALS og andre GDF-8-associerede lidelser DK2407486T3 (da)

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EP06801434.9A EP1915397B1 (en) 2005-08-19 2006-08-14 Antagonist antibodies against gdf-8 and uses in treatment of als and other gdf-8-associated disorders

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EP (3) EP1915397B1 (da)
JP (2) JP5415071B2 (da)
CN (2) CN103450359B (da)
AU (1) AU2006283725B2 (da)
BR (1) BRPI0614893A2 (da)
CA (1) CA2619491C (da)
DK (2) DK1915397T3 (da)
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HK (1) HK1119716A1 (da)
HU (2) HUE038324T2 (da)
MX (1) MX2008002367A (da)
PL (2) PL1915397T3 (da)
PT (2) PT2407486T (da)
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